FDA Clarifies Korean Molluscan Shellfish Ban

WASHINGTONThe U.S. Food and Drug Administration (FDA) on May 25 issued a constituent update clarifying its May 1 ban of certain the types of fresh, frozen or processed molluscan shellfish, including oysters, clams, mussels and scallops, imported from Korea. FDA considers Korean molluscan shellfish to unsafe for human consumption because it no longer meets the sanitation controls spelled out under the National Shellfish Sanitation Program.

The earlier language was FDA recommends that food distributors, retailers and foodservice operators remove from sale or service, all fresh, frozen and processed Korean molluscan shellfish and any product subsequently made with them." In response to questions posed over processed molluscan shellfish, FDA changed the language to FDA recommends that food distributors, retailers, and foodservice operators remove from sale or service, all fresh, frozen and processed (including canned) Korean molluscan shellfish and any product subsequently made with them."

Korean molluscan shellfish represents only a small fraction of the oysters, clams, mussels, and scallops sold in the United States. FDA is currently working to determine the distribution of the product.

On May 1, FDA removed all Korean certified shippers of molluscan shellfish (oysters, clams, mussels, and scallops) from the Interstate Certified Shellfish Shippers List (ICSSL), following a comprehensive FDA evaluation that determined that the Korean Shellfish Sanitation Program (KSSP) no longer meets the sanitation controls spelled out under the National Shellfish Sanitation Program.

The removal of Korean shellfish shippers from the ICSSL is intended to stop the import of molluscan shellfish harvested from polluted waters. Korean molluscan shellfish that entered the United States prior to May 1 and any product made with Korean molluscan shellfish are considered adulterated under the Federal Food, Drug, and Cosmetic Act.

FDAs evaluation of the KSSP found significant shellfish growing area deficiencies including, ineffective management of land-based pollution sources that can impact shellfish growing areas; inadequate sanitary controls to prevent the discharge of human fecal waste from fish farms and commercial fishing and aquaculture vessels operating in and adjacent to shellfish growing areas; and, detection of norovirus in shellfish growing areas analyzed by FDA during the evaluation. Because of inadequate sanitation controls, the molluscan shellfish harvested from Korean waters may have been exposed to human fecal waste and have the potential to be contaminated with norovirus.